Pharmaceutical Packaging Testing: ISO 17025 and ISTA Accredited Test Lab

Pharmaceutical Packaging Testing

Whether it be accelerated aging, seal strength, cold chain, or standard package testing, Keystone Package Testing can meet the transit testing needs of pharmaceutical companies. We are an ISO-17025 accredited test lab and our team creates an accurate test plan and provides reports in a timely manner. Having a large lab, we can often provide immediate scheduling. We also can test individual boxes up to oversized pallets.

Ready to get started? Request a quote to see why so many pharma companies partner with Keystone Package Testing. Contact us to receive more information on pharmaceutical package testing.

Summary of Pharmaceutical Package Transportation Testing

Pharmaceutical packaging ranges widely depending on the chemical makeup of the drug or vaccine. Packages should be able to withstand the stresses of manufacturing, storage, transportation, and distribution.

Manufacturing, distribution, and transportation are the areas that pharmaceuticals experience the most stress. The distribution channel can be tough on the packaging. From drops, shakes, and temperature variations, it is imperative that a package is able to maintain its integrity throughout the process.

Pre-conditioning and conditioning tests are common types of testing for changes in temperature and humidity. Exposing the package to these types of environmental stresses allows the lab to check the effects on the integrity of the package. Should the package warp or deteriorate due to the simulated stresses, it should still maintain sterility and the ability to protect the product inside.

Additionally, dealing with pharmaceutical packages, sterility is an important component of distributing pharmaceutical products. The seal on the packaging must be composed in such a way that it will not break and result in a breach of sterility.

Why is Pharmaceutical Packaging Testing and Integrity Important?

Regardless of the specific type of package, it is important for the drug or vaccine to reach its destination ready to be administered to those who need it.

Product Safety

Pharmaceuticals are often sensitive to environmental conditions such as temperature, humidity, and light. Proper packaging and transportation integrity testing help protect drugs from external factors that could compromise their stability and effectiveness. Ensuring the safety of pharmaceutical products is paramount to avoid adverse effects on patients.

Product Efficacy

Pharmaceutical products need to maintain their desired chemical and physical properties to be effective. Packaging and transportation testing help verify that drugs remain potent and deliver the expected therapeutic benefits to patients. Any deterioration during transport or storage can lead to reduced efficacy and potentially jeopardize patient outcomes.

Regulatory Compliance

Health authorities worldwide, such as the FDA in the United States or the European Medicines Agency (EMA) in Europe, enforce strict regulations and guidelines for pharmaceutical packaging and transportation. Compliance with these regulations is essential for pharmaceutical companies to gain approval for their products and maintain market access.

Avoiding Contamination

Proper packaging prevents pharmaceuticals from being contaminated by external elements, including dust, microorganisms, or other potentially harmful substances. Similarly, transportation integrity testing ensures that products are not exposed to adverse conditions during transit, preventing contamination or degradation of the drug.

Extended Shelf Life

Well-designed packaging that withstands transportation challenges can help extend the shelf life of pharmaceutical products. This is particularly important for drugs with a longer shelf life or those destined for distribution in remote areas.

Cost Efficiency

Adequate packaging and transportation testing can reduce the likelihood of damage or loss of pharmaceutical products during transit. Minimizing losses due to damaged goods can result in cost savings for pharmaceutical companies and healthcare systems.

Reputation and Brand Image

The pharmaceutical industry relies heavily on its reputation for delivering safe and effective drugs. Failure to maintain product integrity during packaging and transportation can lead to negative publicity, legal issues, and loss of consumer trust.

Common Pharmaceutical Package Testing Types

Accelerated Aging

The accelerated aging packaging test is the process of introducing temperature and humidity to expedite the deterioration of materials. Oftentimes, a sterile barrier system has an expiration date because sterility can no longer be guaranteed. Over time, the adhesive materials or cohesive bonds that maintain sterility begin to degrade and the package is compromised.

For more information on Accelerated Aging, please visit the links:

Gross Leakage / Dye Penetration

ASTM F2096, known as the Bubble Test, measures the material integrity of the package. This test consists of submerging the package under water and increasing the internal pressure of the package. Dye penetration package testing is useful for measuring the effectiveness of package seals for a complete seal that will keep the drug sterile under stressful conditions.

Seal Strength

ASTM F88 only tests a portion of the seal. This test measures the force required to separate a test strip of material containing the seal. ASTM F88 also identifies the mode of specimen failure.

ASTM F2824 tests the force required to separate the entire lid from a container. This test differs from ASTM F88. ASTM F2824 uses an angle of 45 degrees to determine the maximum forces required to separate the lid. However, other angles of pull may be acceptable.

Cold Chain

Pharmaceuticals that have a short shelf life may require Thermal or Cold Chain Packaging to maintain a regulated temperature. These pharmaceutical packages must endure precise temperatures ranging from 2 degrees Celsius to 10 degrees Celsius.

ASTM F2825 is used for the climatic stressing of overnight or two-day delivery systems of a single parcel. The ASTM F2825 testing procedure does not cover refrigerated, frozen food storage, or cryogenic storage conditions.

NSF/ANSI 456 defines criteria for units used to store vaccines. This type of testing consists of refrigerators, freezers, and combination units. Maintaining critical refrigeration and freezer temperatures for vaccines, such as SARS-CoV-2, has created a unique class of storage devices compared to traditional residential and commercial refrigeration units.

Pharmaceutical Package Integrity Testing

Expert Laboratory Pharmaceutical Packaging Testing

At Keystone, we test to make sure specific package regulations are met. We also ensure that the pharmaceuticals reach their destination safely and are ready to be administered. Below is a list of the most common tests that can be used specifically for pharmaceuticals.

Pharmaceutical companies partner with us for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion.

Contact us or request a quote to see why customers appreciate the transparency and experience that we bring to every test. We look forward to working with you!

 

Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.